Retired since November 2019

Supporting and act as back up of the Head of PMO department. Supporting and promoting Quality management, best practices and process improvements.Support to training initiatives and Training needs analysis development. Preparation, revision/coordination of Project Management SOPs and Guidelines.Preparation of Executive Monthly Management Reports on Clinical Studies status and other KPIs.Preparation and internal newsletter (GCP, Regulatory & clinical intelligence, knowledge… Show more Supporting and act as back up of the Head of PMO department. Supporting and promoting Quality management, best practices and process improvements.Support to training initiatives and Training needs analysis development. Preparation, revision/coordination of Project Management SOPs and Guidelines.Preparation of Executive Monthly Management Reports on Clinical Studies status and other KPIs.Preparation and internal newsletter (GCP, Regulatory & clinical intelligence, knowledge sharing). Implementation, support and management of Intranet webpages and internal tools (e.g. Resource Management database, Vendors database, CTMS, etc.) Show less

Support and back up of the Vice President, Global Training and Quality Management.Definition and implementation of Training process and TQM infrastructure following the merger of different legacy companies. Development and delivery of Training materials. Introduction of company onboarding training for new employees.Responsible for development and delivery of training across Western Europe.Manage and support a training needs analysis across the business and develop/deliver materials… Show more Support and back up of the Vice President, Global Training and Quality Management.Definition and implementation of Training process and TQM infrastructure following the merger of different legacy companies. Development and delivery of Training materials. Introduction of company onboarding training for new employees.Responsible for development and delivery of training across Western Europe.Manage and support a training needs analysis across the business and develop/deliver materials according to those needs.Line manager of resources in Western Europe, US and CIS. Show less

• Coordinates, plans, and conducts CQA audits globally• Issue reports, perform analysis of audit results, and effectively communicate and document GCP issues to Management• Lead or contribute to GxP audits, jointly conducted with GMP/GLP auditors• Coordinates inspectional activities, including Investigator and/or Sponsor inspections, both locally and abroad. • Provide GCP guidance and interpretation of regulations• Proactively research local and international GCP trends and… Show more • Coordinates, plans, and conducts CQA audits globally• Issue reports, perform analysis of audit results, and effectively communicate and document GCP issues to Management• Lead or contribute to GxP audits, jointly conducted with GMP/GLP auditors• Coordinates inspectional activities, including Investigator and/or Sponsor inspections, both locally and abroad. • Provide GCP guidance and interpretation of regulations• Proactively research local and international GCP trends and initiatives to ensure compliance Show less

• Member of Global network with coordinating responsibilities on 6 South Europe countries• Responsible for QA/QC activities within Clinical Development Department and for supporting management during regulatory and/or certification inspections• Providing interpretation of GCP regulations, guidelines, policies and procedures• Acknowledge and impact evaluation of Global SOPs on local activities in line with local laws/requrements • Monitoring and ensuring compliance (also… Show more • Member of Global network with coordinating responsibilities on 6 South Europe countries• Responsible for QA/QC activities within Clinical Development Department and for supporting management during regulatory and/or certification inspections• Providing interpretation of GCP regulations, guidelines, policies and procedures• Acknowledge and impact evaluation of Global SOPs on local activities in line with local laws/requrements • Monitoring and ensuring compliance (also through Procedural Compliance Reviews) with Global and Local SOPs to support the clinical project plans • Mentor CRAs and develops and implements GCP training programs to help study management and enhance professional development. Show less

Responsible for training of Clinical Research personnel in GCP rules, global operating procedures and local rules.European Training Manager, member of the AZ Global Learning and Development Group and speaker at international training events/courses.Responsible for on site training and professional development of Clinical Research AssociatesResponsible for Quality Control activities within Clinical Research Department

Rsponsible for Clinical Trial Planning and MonitoringExecution of Clinical Trials according to GCP and FDA rules